Configure subject in the report header

The Subject of Report tab is used to configure the report header and to specify the agency, products, etc. for which the CTPR is applicable.

Field Description

Available Reporting Destination

Displays the list of configured Regulatory Agencies. Select an agency from the list displayed in Reporting Destination and click Add to add the report to the Selected Destination list.

Select multiple agencies by holding the CTRL key when you click them.

Likewise, select an agency from the Selected Destination list and click Remove to remove it from the selected destination.

Primary Agency

Select the primary agency for the report.

When you submit a Periodic report, it goes to the selected Primary Agency.

Selected Reporting Destination

Displays the list of agencies where the report is being sent. Select an agency from the list displayed in Reporting Destination and click Add to add the report to the Selected Destination list.

Select multiple agencies by holding the CTRL key when you click them.

Likewise, select an agency from the Selected Destination list and click Remove to prevent it from being sent to the selected destination.

Ingredient

Automatically displays the Ingredient as provided in the Subject of Report dialog box.

You can choose whether to view this field or not. Click the checkbox displayed with this field to hide or view it.

Trade Name

Automatically displays the Trade Name(s). Multiple trade names are also displayed together, separated by commas.

You can choose whether to view this field or not. Check the checkbox displayed with this field to hide or view it.

International Birth Date

Automatically displays the earliest license awarded date, when a user selects an Ingredient and a Product.

You can choose whether to view this field or not. Check the checkbox displayed with this field to hide or view it.

Print all configuration criteria on separate cover page

Mark this box to print out the configuration of this report when the report is printed. This is only available when PDF option is selected during printing.

Print page numbers on reports

When checked, this option enables the user to print page numbers on a periodic report. This is the default for all report configurations.

If this checkbox is not checked, the following occur.

  • The Include Periodic Page Numbering option in the CTPR Summary Tabulations CIOMS Report section is inactive and grayed out.
  • The User Periodic Numbering on the report option on CTPR Summary Tabulations FDA CTPR support section is grayed out and inactive.
  • The Additional Separate Page Numbering for UD Summaries option on the CTPR UD Summaries tab is grayed out and inactive.
  • The system removes all existing report page numbering and the option to check page number checkboxes on the report configuration tabs are grayed out and inactive.

Allow access to report cases through Case Series

When the report is run as final, it creates a Hit List, which can be retrieved from other areas of the application where advanced conditions can be selected. Click this checkbox to report cases through the Hit List.